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In a phase II trial reported in The Lancet Oncology, Wilky et al found evidence of activity of axitinib plus pembrolizumab in advanced sarcomas, including alveolar soft-part sarcoma. Study Details The study involved 33 patients with advanced or metastatic sarcomas, including alveolar soft-part...
In a single-center phase II trial reported in the Journal of Clinical Oncology, Nie et al found a higher complete response rate with the addition of low-dose decitabine to the programmed cell death protein 1 (PD-1) inhibitor camrelizumab in anti–PD-1 treatment–naive patients with...
ALTHOUGH IMMUNOTHERAPIES have had limited success in pancreatic cancer to date, findings from a molecular analysis of the tumor microenvironment suggest that certain subtypes may be more responsive to treatment. According to data presented at the 2019 Society of Surgical Oncology Annual Cancer...
USE OF the anti–programmed cell death protein 1 (anti–PD-1) checkpoint inhibitor pembrolizumab after two or more prior lines of therapy led to responses in patients with advanced small cell lung cancer (SCLC) in a pooled analysis of two clinical trials: phase Ib KEYNOTE-028 and phase II...
THE 2019 American Association for Cancer Research (AACR) Annual Meeting was held March 29 to April 3 in Atlanta. In addition to our regular coverage of news stories from the meeting, here are some brief highlights of additional noteworthy studies. Stage IV HER2-Positive Breast Cancer: Surgery or No ...
NAMRATA VIJAYVERGIA, MD, of Fox Chase Cancer Center, Philadelphia, commented on this study. “This is an important study because it is done in a rare tumor type; not a lot of clinical trials are conducted in this disease. Recently, three other studies of single-agent therapy with checkpoint...
COMBINING TWO established immunotherapy agents achieved tumor shrinkage in rare, aggressive, extrapancreatic high-grade neuroendocrine tumors, according to the results of SWOG S1609, a phase II clinical basket trial also known as DART (Dual Anti– CLTA-4 and Anti–PD-1 Blockade in Rare Tumors). The...
THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...
ACCORDING TO DATA from a small prospective study presented at the 2019 Society of Surgical Oncology Annual Cancer Symposium,1 neoadjuvant immunotherapy significantly prolonged relapse-free survival vs adjuvant immunotherapy in patients with stage III or oligometastatic stage IV melanoma intended...
In a phase I trial reported in The New England Journal of Medicine, Raje et al found that bb2121, a chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA), was safe in heavily pretreated patients with relapsed or refractory multiple myeloma. Investigators reported ...
In a research letter published in JAMA Oncology, Quach et al found that cutaneous toxicities related to anti–programmed cell death protein 1 (PD-1) treatment—specifically, vitiligo and rash—were associated with improved clinical outcomes in advanced melanoma. Study Details The...
In a systematic review and meta-analysis reported in JAMA Oncology, Wang et al characterized treatment-related adverse event profiles associated with monotherapy use of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors in clinical trials. Study Details...
In the phase III NRG Oncology/Gynecologic Oncology Group (GOG)-252 study reported in the Journal of Clinical Oncology, Walker et al found no progression-free survival benefit of postsurgical intraperitoneal (IP) chemotherapy vs intravenous (IV) chemotherapy, each combined with bevacizumab, in...
As reported in JAMA, Singal et al used a clinicogenomic database in routine clinical practice to identify associations between treatment outcomes and patient characteristics or tumor genomic profiles in the setting of non–small cell lung cancer (NSCLC). The study cohort of 4,064 patients...
In the phase III IMblaze370 trial reported in The Lancet Oncology, Eng et al found no survival benefit with third-line atezolizumab with or without cobimetinib vs regorafenib in patients with locally advanced or metastatic colorectal cancer. Study Details The open-label trial included 363...
Earlier this week, the Centers for Medicare & Medicaid Services (CMS) proposed to improve the reimbursement currently given to hospitals that provide chimeric antigen receptor T-cell (CAR-T) therapy to patients with blood cancer as part of the Fiscal Year 2020 Inpatient Prospective Payment...
In a study reported in Clinical Cancer Research, Alexander M. Menzies, MD, of Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, and colleagues found that BRAF V600K melanomas are less responsive to BRAF inhibitor with or without MEK inhibitor...
A phase I clinical trial showed encouraging results with chimeric antigen receptor (CAR) T-cell therapy targeted to the mesothelin protein in patients with mesothelin-associated malignant pleural solid tumors—primarily, malignant mesothelioma—that had progressed following standard platinum-based...
With the recent breakthroughs in immunotherapy, treatments that modulate the immune system are now being used across numerous cancer types and across the spectrum of disease with significant success, but not all patients achieve objective responses. There is still a critical need to better...
On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYNOTE-426 Approval was based on KEYNOTE-426, a randomized, multicenter, open-label trial conducted in ...
As reported in The Lancet by Mok et al, the KEYNOTE-042 trial has shown an improvement in overall survival with pembrolizumab vs standard chemotherapy in previously untreated patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) without a sensitizing EGFR mutation or ...
As reported in the Journal of Clinical Oncology by Chung et al, the phase II KEYNOTE-158 trial showed activity of pembrolizumab in previously treated programmed cell death ligand 1 (PD-L1)-positive advanced cervical cancer. The study supported the 2018 accelerated approval of pembrolizumab in this...
Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....
Maintenance immunotherapy did not improve survival in patients with extensive-stage small cell lung cancer (SCLC), according to late-breaking results from the CheckMate 451 study presented today by Owonikoko et al at the European Lung Cancer Congress 2019 (Abstract LBA1_PR). Around 60% to 70% of...
Two studies reported at the European Lung Cancer Congress (ELCC) 2019 provided new insights on the efficacy and safety of immunotherapy in elderly patients with advanced non–small cell lung cancer (NSCLC). Although around half of all people newly diagnosed with NSCLC are elderly (Pallis ...
THE DISCUSSANT of the abstract was Kunle Odunsi, MD, PhD, Cancer Center Deputy Director, Chair of the Department of Gynecologic Oncology, and Executive Director of the Center for Immunotherapy, at Roswell Park Comprehensive Cancer Center, Buffalo, New York. He emphasized the large number of...
IN HIGH-RISK patients with breast cancer and low expression of HER2 (HER2 low), a peptide vaccine targeting HER2, combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), and given concurrently with trastuzumab, may help to prevent recurrence. Final analysis of a randomized phase...
FORMAL DISCUSSANT of the abstract presented by Harding et al, Michael Morse, MD, Professor of Medicine at Duke University Medical Center, in Durham, North Carolina, noted that the authors should be commended on a complex dose-escalation strategy that surely required a lot of collaboration among...
THE EMERGENCE of anticancer agents that block immune checkpoints has transformed the field of oncology, leading to durable responses and improvements in overall survival in melanoma, renal cell carcinoma, head/neck squamous cell carcinoma, urothelial bladder cancer, and non–small cell lung cancer....
INITIAL DATA from the ongoing, multicenter, first-in-human, phase Ia/Ib dose-escalation and -expansion study suggest that an anti–T-cell immunoglobulin domain and mucin domain–containing molecule 3 (anti–TIM-3) antibody alone or in combination with immune checkpoint blockade could counter intrinsic ...
THE COMBINATION of lenvatinib plus pembrolizumab has demonstrated antitumor activity in patients with advanced urothelial cancer, including patients receiving later-line treatment. Results of a phase Ib/II trial showed an objective response rate of 25% and a median progression-free survival of 5.4...
Researchers have identified a new potential immunotherapy target in pancreatic cancer, which so far has been notoriously resistant to treatment with immune checkpoint blockade drugs effective against a variety of other cancers. A research team from The University of Texas MD Anderson Cancer Center...
As part of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on several studies of allogeneic hematopoietic cell transplantation (allo-HCT) and cellular therapy, as used in myelodysplastic syndromes (MDS), acute...
THE FORMAL DISCUSSANT of the KEYNOTE-427 trial, Tracy Rose, MD, MPH, of the University of North Carolina, Chapel Hill, told listeners: “I think pembrolizumab should now be considered an option for non–clear cell kidney cancer. Response rates, however, remain inferior to those seen in clear cell...
IMMUNOTHERAPY WITH the checkpoint inhibitor pembrolizumab may prove to be an effective option for patients with advanced non–clear cell renal cell carcinoma, according to results in cohort B of the KEYNOTE-427 trial, presented at the 2019 Genitourinary Cancers Symposium.1 Response rates were...
In contrast with melanoma, lung cancer, and kidney cancer, immune checkpoint inhibitor therapy has been disappointing in prostate cancer thus far. Because of success in treating other tumor types, interest remains high in exploring the effect of immunotherapy with checkpoint inhibition in prostate...
SOME PATIENTS with metastatic prostate cancer may respond to a combination of immune checkpoint inhibitors after treatment with hormonal therapy and chemotherapy is not successful, according to early results from the phase II CheckMate 650 trial. Principal Investigator Padmanee Sharma, MD, PhD,...
THE COMBINATION of savolitinib and durvalumab achieved durable responses in approximately one-fourth of patients with metastatic papillary renal cell carcinoma in the phase II CALYPSO study.1 Treatment options are limited for papillary renal cell carcinoma. Clinical guidelines recommend enrollment...
THE COMBINATION of pembrolizumab and cabozantinib demonstrated antitumor activity in patients with previously treated metastatic renal cell carcinoma and both drugs were tolerable at their approved doses, according to data from a dose-escalation cohort of a phase I study.1 Among eight patients with ...
NIVOLUMAB PLUS low-dose ipilimumab continued to demonstrate strong responses as well as a survival benefit with a median of 32.4 months of follow-up as front-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma, according to an update of the phase II CheckMate...
THE PROGRAMMED cell death-ligand 1 (PD-L1) inhibitor, avelumab, was combined with the multitargeted vascular growth endothelial factor (VEGF) agent, axitinib, and compared to monotherapy with sunitinib in the first-line treatment of patients with metastatic renal cell carcinoma. Toni K. Choueiri,...
LORI WOOD, MD, of Dalhousie University in Halifax, Nova Scotia, Canada was the formal discussant for the KEYNOTE 426 study presented at the 2019 Genitourinary Cancers Symposium.1,2 Dr. Wood called the KEYNOTE 426 phase III trial “practice-changing,” and added, “The majority of patients with...
AS REPORTED at the 2019 Genitourinary Cancers Symposium by Thomas Powles, MD, and as published in The New England Journal of Medicine by Brian Rini, MD, and colleagues, significant benefits in overall and progression-free survival were achieved with the combination of pembrolizumab plus axitinib...
In an interim analysis of a phase II study reported in The Lancet Oncology, Makker et al found that lenvatinib plus pembrolizumab was active in advanced endometrial cancer. Study Details In the study, 54 patients from 11 sites with metastatic endometrial cancer unselected for microsatellite...
In the phase III AUGMENT trial reported in the Journal of Clinical Oncology, Leonard et al found that the addition of lenalidomide to rituximab significantly prolonged progression-free survival in patients with relapsed or refractory indolent lymphoma. Study Details The double-blind trial...
As reported in the Journal of Clinical Oncology by Van Cutsem et al, treatment with encorafenib, binimetinib, and cetuximab for BRAF V600E–mutant metastatic colorectal cancer was associated with a manageable safety profile and evidence of activity in the safety lead-in to the phase III BEACON ...
A combination of the experimental histone deacetylase (HDAC) inhibitor entinostat with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab showed clinical responses in patients with melanoma that had progressed on prior anti–PD-1 treatment, according to results from the phase...
An interim analysis of a small phase Ib study by O’Hara et al evaluating the CD40 agonistic monoclonal antibody APX005M in combination with gemcitabine and nab-paclitaxel with or without the programmed cell death protein 1 (PD-1) inhibitor nivolumab in untreated patients with metastatic...
The results of an analysis of pooled data from the phase Ib KEYNOTE-028 trial and the phase II KEYNOTE-158 study of the anti–programmed cell death protein 1 monoclonal antibody pembrolizumab in the treatment of advanced small cell lung cancer has found that the therapy provided antitumor...
A small phase I study by Navai et al investigated a combination of lymphodepletion chemotherapy and HER2-specific chimeric antigen receptor (CAR) T-cell therapy for pediatric and adult patients with advanced HER2-positive sarcoma. The combination showed promising antitumor activity and was found to ...